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Trial record 1 of 1 for:    BIONYX
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Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX)

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ClinicalTrials.gov Identifier: NCT02508714
Recruitment Status : Unknown
Verified February 2017 by Clemens von Birgelen, Thorax Centrum Twente.
Recruitment status was:  Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Clemens von Birgelen, Thorax Centrum Twente

Brief Summary:
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Pectoris Unstable Angina Pectoris Acute Coronary Syndrome Coronary Stenosis Coronary Restenosis Device: Orsiro Device: Resolute Onyx Not Applicable

Detailed Description:

rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Aim:

The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.

Study design:

The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.

Study population:

Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.

Intervention:

One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.

Primary study outcome:

Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
Actual Study Start Date : October 7, 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Orsiro DES (Biotronik)
The ORSIRO hybrid coating DES (Biotronik, Switzerland) is a device which includes a modern, highly flexible, thin-strut stent platform, eluting sirolimus from a thin biodegradable BIO-lute coating grom PLLA (poly(L-lactic acid)) which is located mainly on the abluminal side.
Device: Orsiro
stents will be implanted in case of significant coronary artery disease
Other Name: Orsiro drug eluting stent

Active Comparator: RESOLUTE ONYX DES (Medtronic)
The RESOLUTE ONYX is a permanent polymer DES that uses a novel highly flexible metallic stent backbone with increased radiographic visibility eluting the drug zotarolimus from the BioLinx durable polymer coating. The stent platform uses corewire technology that allows the stent to have a denser core metal surrounded by outer layer of cobalt-chromium.
Device: Resolute Onyx
stents will be implanted in case of significant coronary artery disease based on coronary angiography
Other Name: Resolute Onyx drug eluting stent




Primary Outcome Measures :
  1. Target vessel failure (TVF) [ Time Frame: 1 year ]
    Composite endpoint consisting of: Cardiac death (All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established); Target vessel related MI (Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel); Clinically driven repeated target vessel revascularization by means of CABG or PCI.


Secondary Outcome Measures :
  1. Death at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]
    Death distinguished into: cardiac, vascular, other causes, all-cause mortality

  2. Myocardial infarction at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]
    Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction

  3. Revascularization at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]
    Target-vessel revascularization distinguished into PCI or CABG

  4. Stent thrombosis at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]
    Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.

  5. Target lesion failure (TLF) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]
    Composite endpoint consisting of : cardiac death; target vessel-related MI; clinically driven target lesion revascularization (TLR)

  6. Major adverse cardiac events (MACE) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]

    Composite endpoint consisting of:

    1. any death;
    2. any myocardial infarction
    3. emergent CABG;
    4. clinically indicated TLR

  7. Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]
    Composite endpoint consisting of: any death; any myocardial infarction; any revascularization.

  8. Major Bleeding at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]
    Major bleeding that require surgery or blood transfusions or cerebral hemorrhages


Other Outcome Measures:
  1. Longitudinal stent deformation (LSD) and deliverability [ Time Frame: 1 year ]
    Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of 18 years and older, requiring PCI for the treatment of significant coronary artery or bypass graft lesions, being eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement, and capable of providing informed consent.
  • Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location or length of lesions to be treated.

Exclusion Criteria:

  • Known intolerance to components of one of the study DES, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to any dual anti-platelet therapy (DAPT).
  • Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization.
  • Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint.
  • Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508714


Locations
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Belgium
CHU Charleroi
Charleroi, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Israel
Rambam
Haifa, Israel
Netherlands
Haga Ziekenhuis
Den Haag, Zuid Holland, Netherlands, 2504 LN
Rijnstate Hospital
Arnhem, Netherlands
Treant Zorggroep
Emmen, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Sponsors and Collaborators
Thorax Centrum Twente
Investigators
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Principal Investigator: Clemens von Birgelen, MD, PhD Thorax Centrum Twente

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clemens von Birgelen, MD, PhD, Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT02508714    
Other Study ID Numbers: P15-19
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Coronary Stenosis
Coronary Restenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms